# FDA 483 - Crest Electronics Inc - December 28, 2022

Source: https://www.globalkeysolutions.net/records/483/crest-electronics-inc/a38c1edf-dc99-4cb5-b01a-d3d263ff2291

> FDA 483 for Crest Electronics Inc on December 28, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Crest Electronics Inc
- Inspection Date: 2022-12-28
- Product Type: device
- Office Name: Minneapolis District Office
- Summary: Crest Electronics Inc, a medical device manufacturer in Dassel, MN, was cited for multiple quality system deficiencies during an FDA inspection. The firm's procedures for design change, nonconforming product disposition, incoming product acceptance, sampling methods, and process controls were found to be inadequately established. These issues indicate a systemic lack of documented and followed procedures essential for ensuring product quality and regulatory compliance.

## Related Officers

- [Investigator ](https://www.globalkeysolutions.net/people/christina-l-bigham/f3da8e26-4a8c-43a8-8070-349fe4500289)

Company: https://www.globalkeysolutions.net/companies/crest-electronics-inc/fef62934-834e-4208-99cf-6477ce5755e6

Office: https://www.globalkeysolutions.net/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d